LA, Congress take divergent paths after test warning

LOS ANGELES >> Los Angeles will continue using a coronavirus test that federal regulators warned may produce false results while Congress, which has used the same test, is seeking an alternative.

The different responses Thursday followed a Food and Drug Administration alert to patients and health care providers that Curative’s test, which is used in some of the nation’s largest cities, could particularly produce false negatives. Those faulty results pose the biggest risk from a health perspective because people who are erroneously told they don’t have the virus can unknowingly spread it.

The warning comes as California copes with its worst surge of the pandemic and some of the highest levels of COVID-19 in the country. Hospitals in Los Angeles and across the southern half of the state are overwhelmed with patients, oxygen used for treatment is running low and ambulances sometimes wait hours to unload patients.

Curative, a California startup company, said in a statement it was working with the FDA to address concerns and would provide additional data to address test limitations and precautions highlighted by the agency. The company said its test was the most clinically sensitive available at scale and its performance had not changed.

The FDA offered no information on what triggered the warning Monday, but it appeared to be about the test’s accuracy for people who don’t exhibit symptoms of COVID-19, such as fever, sore throat and fatigue.

Dr. Clemens Hong, who oversees coronavirus testing for Los Angeles County, said the company’s initial emergency use authorization from the FDA was based on a limited study of subjects with coronavirus symptoms. The company later performed a clinical study involving asymptomatic subjects but the FDA balked at approving use for people without symptoms.

“They actually feel that those data don’t support the use of the (test) in asymptomatic individuals and there’s a little bit of a disagreement between Curative and the FDA,” Hong said.

Mayor Eric Garcetti, who embraced Curative and opened testing to everyone last spring when tests were in short supply elsewhere, stood by the company Thursday. He said a third of all positive test results in the city have been in people without symptoms.